Drug Information

Drug Interaction:

Drug interaction- summary -

Vaccines-

Because of potential inteference between the attenuated influenza vaccine and zanamivir
do not administer live vaccine withi 2 weeks of before or after administration of zanamivir

Indication:

U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08

Drug name Indication Date of Approval

23. Zanamavir inhalation powder 5mg/blister 22-01-08

(Addl.Indication)

For prophylaxis and treatment of both influenza A & b in

adult and children (greater than or equal to 5 years)

U.S.FDA APPROVED DRUGS DURING 2006

14. Zanamavir inhalation powder 5mg/blister 13-02-2006 For influenza

RELENZA® (zanamivir) Inhalation Powder, for oral inhalation

Initial U.S. Approval: 1999

RECENT MAJOR CHANGES

Indications and Usage

Important Limitations on Use of RELENZA (1.3) October 2008

Warnings and Precautions Neuropsychiatric Events (5.3) February 2008

LIST OF DRUGS DURING 2006

Sr.No- 14

Name of the Drug- Zanamavir inhalation powder 5mg/blister Pharmacological Classification- For influenza

Date of Approval- 13-02-2006

Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Zanamavir inhalation Influenzae 13-02-2006

Powder 5mg/ Blister

2.Zanamavir Inhalation 22-01-2008

Powder 5mg/ Blister

Addl.Indcn

For Prophylaxis and Treatment of Both Influenza A &B in adults and

children (greater than or equal to 5 years)

Influenza

Adverse Reaction:

Adverse reactions-

CNS - dizziness 2% headache 1%

GI - diarrhea 2% nausea 2% vomiting 2%

Respiratory - bronchitis 2% cough 1% ear , nose and throat infections 1%
sinusitis 1%

Contra-Indications:

History of allergic reactions

Special Precautions-

Bronchospasm - zanamivir is not recommended for the treatment or prophylaxix of
influenza in individuals with underlying airway disease eg asthma, chronic obstructive
disease.
Serious bronchospasm including fatalites have been reported.

Bacterial infections- serious bacterial infections may begin with infulenzalike symptoms or
may coexist as complications during course of treatment. Zanamivir has not shown to prevent
such complications-

Hypersensitivity reactions- allergic reactions including serious skin rashes, and anaphylaxis
have been reported

Pregnancy- use zanamvir during pegnancy only if the potential benefits justies the potential
risk to the fetus.

Lactation- excercise caution when zanamvir is administered to a breast feeding woman

Children-safety and efficacy in children have not been established fortreatment of influenza
in children

Elderly- No overall differences in safety and efficacy were observed beteween elderly
and younger patients during administration

Monitoring- Closely monitor patientsith inflenza for signs of abnormal behaviour

Dosages/ Overdosage Etc:

Indication-

Influenza

Dosage-
Usual dosage- 10mg inhaled once daily for 10 days. The dose be administered at the same
time each day.

INDICATIONS AND USAGE

RELENZA,an influenza neuraminidase inhibitor, is indicated for:

Treatment of influenza in patients 7 years of age and older who have been

symptomatic for no more than 2 days.

Prophylaxis of influenza in patients 5 years of age and older.

Important Limitations on Use of RELENZA:

Not recommended for treatment or prophylaxis of influenza in:

Individuals with underlying airways disease.

Not proven effective for:

Treatment in individuals with underlying airways disease.

Prophylaxis in nursing home residents.

Not a substitute for annual influenza vaccination.

Consider available information on influenza drug susceptibility patterns

and treatment effects when deciding whether to use RELENZA.

-

DOSAGE AND ADMINISTRATION

Indication Treatment of Influenza

Dose 10 mg twice daily for 5 days

Dose

Indication Prophylaxis: Household Setting Community Outbreaks

Dose 10 mg once daily for 10 days 10 mg once daily for 28 days

Note: The 10 mg dose is provided by 2 inhalations

(one 5 mg blister per inhalation).

DOSAGE FORMS AND STRENGTHS

Four 5 mg blisters of powder on a ROTADISK® for oral inhalation via DISKHALER®.

Packaged in carton containing 5 ROTADISKs (total of 10 doses) and

1 DISKHALER inhalation device.

Patient Information:

1. Instruct patients to use of the delivery system, Include a demonstration whenever possible

2. Advice patients that use of zanamvir forvtreatment o influenza has not shown to reduce the risk of transmission of influenza to others.

3. Advice patients the risk of bronchospasm especially in setting of underlying airway disease and to stop zanamvir and contact their doctor if they experience increased respiratory symptoms.

4. If zanamvir is prescribed to childen it should be used only under adult supervision

Pharmacology/ Pharmacokinetics:

CLINICAL PHARMACOLOGY

1. Mechanism of Action

Zanamivir is an antiviral drug

2. Pharmacokinetics

Absorption and Bioavailability: Pharmacokinetic studies of orally inhaled zanamivir

indicate that approximately 4% to 17% of the inhaled dose is systemically absorbed.

The peak serum concentrations ranged from 17 to 142 ng/mL within 1 to 2 hours

following a 10 mg dose. 320 The area under the serum concentration versus time

curve (AUC) ranged from 111 to 321 1,364 ng.hr/mL.

Elimination:

The serum half-life of zanamivir following administration by oral inhalation ranges

from 2.5 to 5.1 hours. It is excreted unchanged in the urine with excretion of a single

dose completed within 24 hours. Total clearance ranges from 2.5 to 10.9 L/hr.

Unabsorbed drug is excreted in the feces

Pregnancy and lactation:

Pregnancy-
Use zanamvir during pegnancy only if the potential benefits justies the potential
risk to the fetus.

Lactation- Excercise caution when zanamvir is administered to a breast feeding woman

Children-
Safety and efficacy in children have not been established fortreatment of influenza
in children

Elderly-
No overall differences in safety and efficacy were observed beteween elderly
and younger patients during administration

Zanamivir - @ - Antiviral agents- (Jan 2008)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Pregnancy and lactation